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The Turbo-Elite devices are indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions.

The 0.014" and 0.018" Over-the-Wire (OTW) Turbo-Elite laser catheters are also indicated for use as an accessory to the use of the Turbo-Tandem System in the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, when used in conjunction with Percutaneous Transluminal Angioplasty (PTA).

Spectranetics Turbo-Elite Laser Ablation Catheters are percutaneous intravascular devices constructed of multiple optical fibers arranged around a guidewire lumen for Over-the-Wire (OTW) configurations, and bundled together for Rapid-Exchange (Rx) versions. Turbo Elite Laser Ablation Catheters are available in an Over the Wire (OTW) configuration and a Rapid Exchange (RX) configuration. The Turbo-Elite laser catheters in the OTW configuration are available in six different catheter tip sizes (0.9mm, 1.4mm, 1.7mm, 2.0mm, 2.3mm, and 2.5mm) and three different guide-wire compatibilities (0.014″, 0.018″, and 0.035"). New indication clearance is only being requested for the OTW configurations of Turbo-Elite catheters compatible with 0.014" and 0.018" guidewires.

The multifiber laser catheters transmit ultraviolet energy from the Spectranetics CVX-300® Excimer Laser System to an obstruction in the patient's artery. The ultraviolet energy is delivered to the laser catheter to photoablate fibrous, calcific, and atheromatous lesions, thus recanalizing diseased vessels. Photoablation is the process by which energy photons cause molecular bond disruption at the cellular level without thermal damage to surrounding tissue.

The provided text is a 510(k) summary for a medical device (Spectranetics Turbo-Elite Laser Atherectomy Catheters). It focuses on establishing substantial equivalence to a predicate device and expanding indications for use. While it mentions a clinical study (ABLATE), it does not provide acceptance criteria in the form of a table with specific device performance numbers, nor does it detail all the specific information requested in the prompt regarding the study's methodology for acceptance testing as if it were an AI/ML device.

However, I can extract the information that is present and indicate where information is missing based on the prompt's requirements.

Missing Information Acknowledgment:
The document does not include details typically found in studies proving an AI/ML device meets acceptance criteria, such as:

• A table of specific numerical acceptance criteria (e.g., minimum sensitivity, specificity, or accuracy thresholds for an AI/ML diagnostic device).
• Information on test set sample size for AI validation.
• Data provenance for AI training/test sets.
• Number/qualifications of experts for AI ground truth.
• Adjudication methods for AI ground truth.
• MRMC comparative effectiveness study results (AI vs. without AI).
• Standalone performance for an algorithm.
• Ground truth type for AI (e.g., pathology, outcomes data).
• Training set sample size for AI.
• How ground truth for the training set was established for AI.

This is because the device described, the "Spectranetics Turbo-Elite Laser Atherectomy Catheters," is a physical medical device (a laser catheter) and not an AI/ML software device. The clinical study mentioned (ABLATE) is designed to demonstrate the safety and effectiveness of the physical device for its intended use in treating infrainguinal stenosis and occlusions, not to validate an AI/ML algorithm's performance against specific metrics.

Based on the provided text, here is the available information related to the clinical study and device performance, rephrased to fit the prompt's structure where possible, and explicitly noting missing AI/ML-specific details:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here refer to the primary safety and effectiveness endpoints of the ABLATE clinical study for the physical device, not an AI/ML algorithm.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size (Test Set): Not explicitly stated numbers of patients in the ABLATE clinical study.
• Data Provenance:
  • Country of Origin: Not specified in the provided text.
  • Retrospective or Prospective: The ABLATE study is referred to as a "clinical study," which typically implies a prospective design for gathering safety and effectiveness data for device approval.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of Experts: Not specified.
• Qualifications of Experts: The "Angiographic Core Lab" is mentioned for assessing reduction in percent stenosis, implying expert (likely interventional cardiologists or radiologists specializing in vascular imaging) review, but no specific qualifications or numbers are provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not specified.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. This is a physical device, not an AI/ML system. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not applicable and was not conducted. The study evaluated the direct impact of the laser atherectomy catheter.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No. This is a physical device, not an AI/ML algorithm. Standalone algorithm performance is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the physical device, the "ground truth" for effectiveness and safety endpoints included:

• Clinical Outcomes Data: Major Adverse Events (MAE) and Target Lesion Revascularizations (TLR) are clinical outcomes.
• Angiographic Assessment: "Mean reduction in percent stenosis at the time of the procedure by Angiographic Core Lab assessment" serves as a measure of the device's immediate effectiveness against a measurable anatomical change.

8. The sample size for the training set

• Not applicable. This is a physical device undergoing a clinical trial for safety and effectiveness, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

• Not applicable. This is a physical device approval, not an AI/ML algorithm.

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